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Patient Registries & Observational Studies

PPD delivers essential knowledge about drug use and treatment outcomes in real-world clinical practice through our post-approval patient registries and observational studies group. Our epidemiology, operations, safety and therapeutic experts design and implement the ideal study to:

  • Meet market challenges successfully
  • Address FDA safety commitments
  • Collect the data you need to demonstrate your product's true value

Full Scope of Services

We have successfully managed observational studies ranging in size from a few hundred sites and patients to those involving thousands of sites and tens of thousands of patients across all major therapeutic areas.

With more than 15 years of scientific, clinical and operational experience in late stage research, our team has conducted studies that have supported or assessed:

  • Regulatory authority requirements and commitments for post-approval safety surveillance
  • Physician practice patterns
  • Unmet medical needs/off-label use
  • Real-world clinical and patient-reported outcomes
  • Physician adherence to established treatment guidelines
  • Health care resource utilization data to support reimbursement
  • Fetal exposure outcomes
  • Burden of illness

Patient Registry & Observational Study Services

PPD provides the following services:

  • Clinical monitoring and quantifying risk potential by collecting real-world safety data
  • Assessment of real-world patient outcomes, including quality of life and treatment satisfaction to better communicate product value
  • Development and execution of observational studies to provide understanding of product effectiveness in patient populations broader than controlled clinical trials
  • Identification of disease and treatment challenges to develop evidence-based treatment guidelines

Health Outcomes Measures

Measuring health outcomes is a key objective for registries and observational studies. Whether the scope is clinical, economic or patient reported, health outcomes measures provide insights that can lead to better patient management, more cost-effective treatment models and improved treatment satisfaction. PPD provides the ability to tweak existing measurement instruments or to design customized new ones to meet clients’ needs and study objectives. These instruments can be implemented to collect:

  • Physician practice patterns and decision drivers
  • Quality of life
  • Health/functional status
  • Health care resource utilization
  • Treatment satisfaction and preference
  • Patient adherence

Pregnancy Registries

PPD is a leading global provider of pregnancy registries and other study methodologies to assess the effects of exposure to medicinal products during pregnancy.

Pregnancy and Lactation Studies

Review a list of PPD’s current pregnancy and lactation studies.

Clinical Monitoring

Our skilled CRAs ensure the highest quality review of clinical data and effective interaction with study sites.

Project Management

PPD believes the project manager is the key to a study’s success. We assign project managers who have experience in clinical and late stage research.

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Pregnancy Registry Strategies in Late Phase Development

Explore strategies for pregnancy registries in late stage development.

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